MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; SPINAL EPIDURAL ANESTHESIA KIT

Model Number	DYNJRA2475
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During anesthetizing of her skin for her spinal placement (scheduled c-section), the 25g needle broke off at the hub within her subcutaneous tissue.It was unable to be visualized or palpated.She subsequently underwent cesarean delivery under general anesthesia.She had a ct scan of her lumbar spine which showed the retained needle fragment in the subcutaneous tissue at l1-2 level.Ultimately, it was retrieved under ir [interventional radiology] guidance.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: SPINAL EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 23582488
• Report Number: 23582488
• Device Sequence Number: 18456497
• Product Code: OFT
• UDI-Device Identifier: 10198459081385
• UDI-Public: (01)10198459081385
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/21/2025
• Report Date (Section F): 10/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJRA2475
• Device Catalogue Number: DYNJRA2475
• Device Lot Number: (10)25BBJ518
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 134 KG
• Date Report Sent to FDA: 10/21/2025